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NCT06308562 Clinical Trial

Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

Official title:
A Pilot Study of Fuzzy Wale Compression Stockinet to Evaluate Healing Following Transtibial Amputation for Peripheral Arterial Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06308562
Other study ID # 23-010717
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date August 2024

Study information
Verified date April 2024
Source Mayo Clinic
Contact Vascular Research Team
Phone (507) 538-7425
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to determine if using Fuzzy Wale compression stockinett can assist in reducing the healing time and decrease costs in trastibial amputation patients as compared to standard of care treatment compression stocking.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - >18 years - Male and female - Transtibial amputation expected. - Peripheral arterial disease, Ankle Brachial Index (ABI) and Transcutaneous partial pressure of oxygen (TCP02, if performed) - Diabetes - Tobacco use at any time in past or current use (pack years) - On dialysis (hemodialysis and peritoneal) - Prior contralateral leg amputation - Ability of subject to give appropriate consent or have an appropriate representative available to do so. Exclusion Criteria: - TcPO2 < 20 (Transcutaneous Cutaneous Partial pressure of oxygen) - Known allergies to any of the components of the compression. - Terminal illness or current cancer therapy with chemotherapy - Inability to undergo ongoing care in Rochester. - Lack of cognitive ability to follow instructions or monitor residual limb. - Vulnerable study population - Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Fuzzy Wale Compression Stockinet
EdemaWear is a tubular, circular knit elastic stockinet fabricated with elastic, vertically oriented fuzzy wales, with the compression provided by the elastic, horizontal oriented Lycra® spandex yarns knitted in between. The stockinet is applied from the foot to the popliteal crease, over the affected area. EdemaWear can be applied in direct contact with the skin or over a wound care dressing. Sizing is based on leg circumference. EdemaWear is indicated for edema management of various etiologies (lymphedema, chronic venous insufficiency, congestive heart failure), and optimizing wound healing. The stockinette is often combined with other boxed compression sets. The manufacturer's stated dosage of EdemaWear is 8-12mmHg when used alone.

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Surgical site infection Number of subject presenting with surgical site infections following transtibial amputation. 8 weeks post-operatively
Primary Wound dehiscence Number of subject presenting with wound dehiscence following transtibial amputation. 8 weeks post-operatively
Primary Days on negative pressure wound therapy Number of days that subjects required negative pressure wound therapy 8 weeks post-operatively
Primary Pain control Pain control during healing following transtibial amputation will be measured using the Visual Analog Scale (VAS). VAS scores range from 0-10 with 10 being the worst possible pain and 0 being no pain. 8 weeks post-operatively
Primary Time to prosthetic fitting Number of days from transtibial amputation to prosthetic fitting. 8 weeks post-operatively
Secondary Length of hospital stay Number of days from transtibial amputation to hospital discharge. 8 weeks post-operatively
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